FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3180626
·
Received June 20, 2013
Report
- Report Number
- 3006630150-2013-01293
- Event Type
- Injury
- Date Received
- June 20, 2013
- Date of Event
- May 31, 2013
- Report Date
- May 31, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE LEAD SITE DUE TO SUTURE SLEEVE CAME TO THE SURFACE OF THE SKIN. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE PHYSICIAN JUST MOVED THE SUTURE SLEEVE AND CLEARED OUT SOME SCAR TISSUE. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279801 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |